Olopatadine Nasal Spray Reduces Seasonal Allergy Symptoms in Children
By Deborah Brauser
Medscape Medical News
November 19, 2009 (San Diego, California) — Olopatadine hydrochloride nasal spray 0.6% reduces both nasal and ocular symptoms in children younger than 12 years of age with seasonal allergic rhinitis (SAR), according to a large study presented here at the American College of Allergy, Asthma Immunology (ACAAI) 2009 Annual Scientific Meeting.
"Some past studies have reported that there is an estimated incidence of [SAR] of more than 40% in the pediatric population," said Craig F. La?Force, MD, clinical professor of pediatrics at the University of North Carolina School of Medicine in Raleigh, during his poster presentation of the results.
"Everybody is looking at available treatments for rhinitis in kids," he explained. "Nasal sprays tend to have an effect on congestion that oral medications typically don't. Your options in pediatrics are nasal steroids; there aren't many others. So the idea is to give a nonsteroidal option for the treatment of congestion. That's why everybody would like to see this kind of modality for kids."
Olopatadine, which is both a selective antihistamine and a mast cell stabilizer, is indicated for the relief of SAR symptoms in patients 12 years and older. For this study, the investigators sought to examine its effectiveness in treating these symptoms in younger children.
A total of 2388 patients between the ages of 6 and 11 years were screened, and 1174 were randomized to receive 1 (n?= 294) or 2 (n= 293) sprays of olopatadine per nostril twice daily for 2 weeks or 1 (n?= 294) or 2 (n?= 293) sprays per nostril from a matching vehicle placebo.
"It was basically a seasonal allergy study looking at allergy symptom control," said Dr. La?Force. "These kids were randomized to [olopatadine] in the adult dosage, which is 2 sprays in each nostril twice a day, 1 spray in each nostril, or the vehicle."
SAR symptom severity was rated by all patients twice daily by telephone diary.
Oral and Nasal Symptoms Reduced
The reflective total nasal symptom scores showed that all olopatadine-treated patients had a greater symptom reduction than all patients treated with the vehicle in nasal congestion, rhinorrhea, itchy nose, and sneezing.
These scores showed a significantly greater symptom decrease for the olopatadine 1 spray/nostril group than for the matching vehicle group (24.7% vs 17.9%; P?= .0007). Similar efficacy was seen with the higher dose of 2 sprays/nostril (26.5% vs 20.8%; P?= .0120).
The reflective total ocular symptom scores for itchy and watery eyes were also reduced significantly more in the olopatadine group than in the 1 spray/nostril vehicle group (24.5% vs 6.1%; P?= .0084) and in the 2 sprays/nostril vehicle group (26.3% vs 8.2%; P?= .0010).
"Our results showed that [olopatadine] administered as 1 or 2 sprays in each nostril is statistically superior to the vehicle for this younger patient population, based on reducing both nasal and eye symptoms," summarized Dr. La?Force.
However, he noted that the administration of 2 sprays per nostril of olopatadine "offered no significant improvement over 1 spray per nostril. In other words, 1 spray is just as good as 2, which is much easier to administer."
An Unexpected Benefit
"It's been proven in several studies that a steroid nasal spray can reduce allergy symptoms in the eyes along with nasal symptoms," said executive medical director and past president of ACAAI Bob Lanier, MD, clinical professor of pediatrics at North Texas University in Fort Worth. "This study was an attempt to specifically look at this effect in an antihistamine spray instead of a steroid."
"Allergy is a permanent lifelong trait that you don't really outgrow, contrary to popular opinion," said Dr. Lanier, who was not involved with the study. So over the long term, you'd like to be able to say that the drug you're using doesn't have any potential for accumulation over a period of time. Steroids do have that potential, though small, while antihistamines do not."
"I think the take-away message here is that using a topical medication, be it steroid or antihistamine, may improve not only the organ in which the drug is delivered, but also other organs. It's an unexpected benefit of a nonabsorbed material. I think it's good news in that it's reducing the amount of medicines that people have to be given and, ultimately, it's reducing the cost for them."
Olopatadine Also Demonstrates Safety
Another poster from this study, measuring safety outcomes, was presented at the ACAAI meeting. It showed that no serious adverse events were reported by any of the patients. Also, the incidence of therapy-related adverse events was similarly low across the groups: 5.7% for olopatadine 1 spray/nostril vs 4.0% for matching vehicle, and 6.1% for olopatadine 2 sprays/nostril vs 3.7% for matching vehicle.
Although bitter taste was the most commonly reported adverse event, it occurred in less than 1.5% of the patients in any group.
This study was funded by Alcon Research. Dr. La?Force reports being on the speakers bureau and receiving honoraria from Alcon. Dr. Lanier reports consulting with Alcon in the past, but not recently and not on this study.
American College of Allergy, Asthma Immunology (ACAAI) 2009 Annual Scientific Meeting: Abstracts P-365 and P-363. Presented November?9, 2009.
